Job Summary
A medical technology company has an open position for a Remote Labeling and Promotions Staff Regulatory Affairs Specialist.
Individual must be able to fulfill the following responsibilities:
- Coordinate, prepare, and execute labeling and promotional materials
- Review substantiation for proposed device labeling modifications
- Identify and communicate appropriately quantified risks and mitigation strategies
Qualifications for this position include:
- If Remote - Ability to travel up to 30% (when travel is able to resume safely)
- Bachelor’s degree, preferably master’s degree in life sciences
- Minimum 5 years of strong Regulatory Affairs experience in a medical device company, with strong expertise in labeling and advertising/promotional materials
- Sound understanding of design control processes, FDA, and global regulations and standards
- Ability to manage multiple projects, meet deadlines, and prioritize/organize complex information